UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and change in taste by taking SGLT2 inhibitor in patients with type 2 diabetes
Title of the study (Brief title)	SGLT2 inhibitor and change in taste
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examin if the taste alternate in diabetes patients after taking SGLT2 inhibitor
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	BDHQ
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Type 2 diabetes
Key exclusion criteria	Pregnant women Women who lactaes now
Target sample size	60

Research contact person
Name of lead principal investigator	Ichiro Horie
Organization	Nagasaki University Hospital
Division name	Endocrinology and Metabolism
Address	1-7-1 Sakamoto, Nagasaki
TEL	0958197200
Email	holy197741@me.com

Public contact
Name of contact person	Ichiro Horie
Organization	Nagasaki University Hospital
Division name	Endocrinology and Metabolism
Address	1-7-1 Sakamoto, Nagasaki
TEL	0958197200
Homepage URL
Email	holy197741@me.com

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

Funding Source
Organization	Nagasaki University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 26 Day
Anticipated trial start date	2015 Year 12 Month 10 Day
Last follow-up date	2017 Year 02 Month 28 Day
Date of closure to data entry	2017 Year 02 Month 28 Day
Date trial data considered complete	2017 Year 05 Month 01 Day
Date analysis concluded	2017 Year 05 Month 05 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/29162514
Results	AIMS: Sodium-glucose cotransporter 2 inhibitors (SGLT2i) cause substantially less weight loss than would be expected based on their caloric deficits, probably due to enhanced appetite regulation known as "compensatory hyperphagia," which occurs to offset the negative energy balance caused by increased glycosuria. We examined whether any specific nutrients contributed to the compensatory hyperphagia in diabetic patients taking SGLT2i. METHODS: Sixteen patients with type 2 diabetes were newly administered dapagliflozin 5mg daily as the experimental SGLT2i group. Sixteen age-, sex- and BMI-matched type 2 diabetes patients not receiving dapagliflozin served as controls. A brief-type self-administered diet history questionnaire (BDHQ) was undertaken just before and 3 months after study initiation to evaluate changes of energy and nutrient intakes in each group. RESULTS: At 3months, daily intakes of total calories and the proportions of the three major nutrients were not significantly increased in either group. However, daily sucrose intake was significantly increased after treatment versus the baseline value in the SGLT2i group (p=0.003), but not in controls. The calculated intakes of all other nutrients were not significantly changed in either group. CONCLUSIONS: Dapagliflozin treatment specifically increased sucrose intake, which might be an ideal target for nutritional approaches to attenuate compensatory hyperphagia.
Other related information	The complete data of the study was published on the journal of Diabetes Research and Clinical Practice as a title of "Increased sugar intake as a form of compensatory hyperphagia in patients with type 2 diabetes under dapagliflozin treatment".

Management information
Registered date	2015 Year 12 Month 10 Day
Last modified on	2018 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023286